Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Enrollment Number
研究概览
简要总结
This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition.
详细描述
In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition. We will randomly assign 21 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the PRISMS or usual care groups (21 patient-caregiver dyads, a total of 42 individuals). PRISMS is defined as a personalized psychoeducational website including monitoring and personal feedback. We will conduct pre- and post-assessments of QOL and PRO (symptoms) at baseline upon enrollment and 2 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must:
- •have been surgically treated for colorectal, bladder, ovarian, cervical, or uterine cancer with curative intent;
- •be within one month of hospital discharge of a newly created ostomy with curative intent;
- •be able to read and speak English;
- •be 18 years or older;
- •have a caregiver who is willing to participate in the study;
- •Caregivers must:
- •be 18 years or older;
- •be able to read and speak English;
- •be identified as the primary caregiver by the patient;
- •have not themselves been diagnosed with cancer or received cancer treatment during the study (to ensure that patients and caregivers focus their efforts on care of the patient).
排除标准
- •Patients and their caregivers will be excluded if they:
- •are unable to read, speak, or understand English;
- •have more than one type of ostomy;
- •have other cancer diagnosis (excluding non-melanomatous skin cancer); or
- •have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).
结局指标
主要结局
Enrollment Number
时间窗: Baseline
The enrollment rate is defined as the number of potentially eligible couples (dyads) who have consented to participate in the study. 1 Dyad = 1 participant + their caregiver. Potentially eligible dyads (subjects and their caregivers) were approached and informed about the study. then the number of dyads who consented and completed.
Number of Potentially Eligible Dyads Participants Actually Enrolled in the Study
时间窗: Baseline, after consent
Potentially Eligible Dyads Participants Actually Enrolled in the Study will be evaluated by the number of dyads who successfully consented and completed the baseline survey among all people approached for the study. 1 Dyad = 1 participant + their caregiver.
Number of Dyads Remained in the Study and Completed the Post-Intervention Follow-Up Survey.
时间窗: Up to 3 months (2-month follow up survey)
The number of dyad Participants Enrolled who Remained in the Study and Completed the Post-Intervention Follow-Up Survey was assessed by the number of enrolled dyad participants who completed the 2-month follow-up survey at the end of the study period.
Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
时间窗: Up to 2 months (Follow up survey)
Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS) evaluates three aspects: General, content, and navigation, contains 19 items on a 5-point Likert scale, where 1 is "strongly disagree" and 5 is "strongly agree". The score for each aspect was calculated as the sum of the scores from all items in this aspect. The scores ranged between 5 and 25 for General and Content, and the Navigation score ranged between 9 and 45. The higher score of the specific aspect that patients and their caregivers reported indicates the better usability of the aspect. This survey was offered separately at the follow-up visit to patients and their caregivers. Participants who completed at least 80.00% of the questions were included in the analysis. Usual Care and Informed Symptom Management System (PRISMS) group scores were compared.
Satisfaction With the PRISMS Program
时间窗: 2-month followup survey
The satisfaction survey evaluates satisfaction with various aspects, contains 9 items on a 5-point Likert scale of 1 to 5, and higher scores reflect better satisfaction. Questions: Q1. The amount of time to review the program every time. Q2. Ease of navigating. Q3. Information I received. Q4. Quality of the information I received. Q5. The program has increased my knowledge about managing my symptoms and complications. Q6. The program has improved how I manage my symptoms and complications. Q7. The program has improved how I communicate with my family about sensitive topics related to my cancer care. Q8. The time and effort took me to complete. Q9. My knowledge about how my cancer has affected my partner and our relationship was improved. This survey was offered at the follow-up visit to patients and their caregivers separately. More than 80.00% of the questions answered were included in the analysis. The mean score for each question for Usual Care and PRISMS were compared.
次要结局
- Difference of Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G).(baseline , 2 months)
- Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a(Baseline and 2 months)
- Difference of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b(Baseline, 2 months)
- Difference Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b(Baseline, 2 months)
- Difference of Fatigue Change Over Time as Assessed by PROMIS Fatigue -Short Form 7a(Baseline, 2 months)
- Change in Sleep Among Caregivers.(Baseline, 2 months)